Wake Forest Alzheimer's Disease Clinical Core

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03140865
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Study Details

Efforts to find treatments for AD have yielded only modest benefits, likely because longstanding AD pathological processes induce irreversible neurological compromise. These processes begin years before the onset of clinical symptoms. This possibility has been incorporated into a model describing stages of AD development, articulated by the NIA/Alzheimer's Association preclinical workgroup of which the Co-Director of the Kulynych Alzheimer's Research Center, Dr. Suzanne Craft, was a member. According to this model, the best hope for countermanding the effects of AD lies in intervening at the earliest possible point in the pathological cascade. There are several important ongoing efforts in adults with preclinical AD that directly target amyloid aggregation. Although this strategy addresses an important aspect of the AD pathological cascade, we believe that addressing metabolic dysfunction affecting glucose and insulin regulation offers a complementary approach, in that it may reduce amyloid burden and toxicity, while also directly enhancing synaptic health, brain metabolism, tau regulation and neurovascular function. The purpose of the ADCC is to identify and characterize early risk factors that predict cognitive decline and dementia in asymptomatic adults and adults with early signs of cognitive impairment. The data obtained from this study, collected at enrollment and follow-up will allow us to examine disease trajectory in individuals with and without prediabetes and other measures of glucoregulatory dysfunction in this process. The enrollees, who will be well-characterized with regard to cognitive and metabolic status through ADCC assessments, will provide an important resource for other local (institution) and national investigations. Data collected from participants enrolled in the ADCC will be stored indefinitely for future investigations.

Key Dates

Start date
Jan 31, 2014
Status verified
Mar 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2031

Study Design

Enrollment
850 participants (estimated)

Arms

  • Arm: Cognitively Normal
    This group will include 300 healthy volunteers with no apparent memory problems. Participants will complete an assessment at enrollment and once per year for the following 5 years. In addition to memory assessments at baseline and year 4, participants will have a brain MRI, OGTT A reliable study partner will need to attend the visits or be available via telephone to complete study interviews.
  • Arm: Mild Cognitive Impairment
    This group will include 400 volunteers who have mild memory problems that are observed during cognitive testing. Participants will complete an assessment at enrollment and once per year for the following 5 years. In addition to memory assessments at baseline and year 4, participants will have a brain MRI, OGTT A reliable study partner will need to attend the visits or be available via telephone to complete study interviews.
  • Arm: Alzheimer's disease
    This group will include 150 volunteers with mild stage Alzheimer's disease dementia. Participants will complete an assessment at enrollment and once per year for the following 5 years. In addition to memory assessments at baseline and year 4, participants will have a brain MRI, OGTT A reliable study partner will need to attend visits to complete study interviews.

Primary Outcome Measure

Change in performance on cognitive measures. [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157
Amy Hughes, AAS
[email protected]
336-716-8634
Jeff Williamson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Wake Forest Baptist Health· Winston-Salem, NC

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